drugset / Trial / NCT01336751

Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment

NCT01336751

Phase 3 Completed 212 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary Objectives : To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * Incidence of hypoglycemia * Change in weight * Change in serum lipid profile * Percentage of subjects achieving A1C levels ≤7%

Timeline

Start
2001-07
Primary completion
2002-12
Completion
2002-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Lispro Protein / enzyme biologic Subcutaneous
Subject insulin glargine Protein / enzyme biologic Subcutaneous